Ethics & Compliance

The procurement of biospecimens can be a highly risky endeavor, especially when it comes to compliance. The iSpecimen MarketplaceĀ® efficiently and thoroughly manages critical aspects of compliance at every stage of the biospecimen procurement process, helping to mitigate risks and instill confidence.

Reducing Risk, Ensuring Compliance

Attention to Detail is the iSpecimen Wayā€”Especially when it Comes to Patient Protection.

From specimen collection to sourcing patient data, we ensure that our suppliers meet all specimen-handling regulations. We process every order with patient privacy as the top priority, obtaining consent from donors and automatically de-identifying patient data upon reception.

Here are six ways iSpecimen incorporates gold standard practices into our specimen procurement process:

1

Strict adherence to exacting regulations

All specimens are collected under the oversight of an IRB/IEC or other appropriate ethics committee. In the U.S., this includes conformance to 45 CFR part 46, HIPAA, 21CFR Part 50/56, and the Uniform Anatomical Gift Act.

2

For research use only

Specimens extracted specifically for research (ā€œHuman Subject Researchā€) are collected under iSpecimenā€™s IRB protocol with informed consent or under our partnersā€™ IRB/IEC protocol with informed consentā€”both of which have been reviewed and approved by iSpecimenā€™s compliance team.

3

Remnant clinical specimens consent requirements

Remnant clinical specimens are collected under a Non-Human Subject Research determination without consent (45 CFR 46 exemption 4), with a waiver of consent, or informed consent, depending on the sourcing institution. Only specimens meeting the specified consent requirements will be delivered.

4

Special guidelines for cadaveric specimens

Cadaver specimens are collected under guidelines set forth by the Uniform Anatomical Gift Act with consent provided by the donor or next of kin.

5

Allowable uses

Our partner network includes a variety of healthcare organizations, each may have their own allowable specimen uses. Ensuring proper specimen handling doesnā€™t have to be risky. Our team tracks and manages this information to help ensure project requirements are met.

6

Patient privacy

iSpecimen goes to great lengths to ensure a patient donorā€™s privacy is protected. Our technology automatically de-identifies patient data before we even receive it from our specimen partners, eliminating the PHI leakage that can happen with manual de-identification processes.